RPT Programs

SK Life Science•Paramus, NJ

About The Position

The Director / Senior Director, Clinical Operations provides strategic and operational leadership for the planning, execution, and oversight of the Company's global clinical development programs, with a primary focus on radiopharmaceuticals, radioligand therapies (RLT), and complex oncology studies. This role is responsible for ensuring Phase I-IV clinical trials are executed in alignment with program objectives, timelines, budgets, quality standards, regulatory requirements, and ICH-GCP. The incumbent leads all aspects of clinical operations for radiopharmaceutical programs, including operational strategy, study execution, CRO and vendor management, resource planning, budgeting, and risk management. The role provides oversight of the unique operational requirements associated with radiopharmaceutical development, including radioactive drug supply, nuclear medicine site readiness, radiation safety, imaging and dosimetry, radioactive specimen collection and shipment, specialty laboratory coordination, and country-specific operational logistics. As a senior clinical operations leader, this individual establishes operational strategies that support high-quality, inspection-ready clinical trials and timely regulatory submissions. The Director / Senior Director partners closely with executive leadership and cross-functional stakeholders—including Clinical Development, Regulatory Affairs, Medical Affairs, CMC, Drug Supply, Quality Assurance, Compliance, Finance, Legal, Project Management, and alliance partners—to drive efficient execution across the clinical portfolio. This role requires an experienced radiopharmaceutical clinical operations leader with the ability to proactively identify and mitigate operational risks, critically evaluate CRO and vendor performance, optimize study budgets and timelines, incorporate regional and site-level considerations, and deliver complex global clinical programs with a focus on quality, compliance, and executional excellence.

Requirements

A minimum of a bachelor's degree in a relevant field is usually required. Common degrees include life sciences, medicine, pharmacy, nursing, nuclear medicine, radiopharmaceutical sciences, oncology, or a related discipline.
Extensive experience (10–15 years) in clinical operations is essential, with at least 5 years of hands-on experience in a radiopharmaceutical environment.
Previous experience in progressively responsible roles within clinical operations, such as Associate / Director of Clinical Operations or equivalent, is typically required.
Extensive experience in managing and leading teams, including experience in a leadership role within clinical operations.
Strong knowledge and understanding of region-relevant clinical trial regulations, guidelines, and industry standards, including GCP and applicable local regulations.
Proven track record of successfully leading the execution of clinical trials (Phase I-IV), generating and compiling the clinical components of a regulatory submission, managing multiple programs, and ensuring adherence to timelines, budgets, and quality expectations.
Expert in working with cross-functional teams and collaborating with other departments such as regulatory affairs, medical affairs, finance, CMC, drug supply, QA, compliance, research and development, and alliance partners.
Broad experience with the development and implementation of clinical operational strategies, processes, and best practices.
Broad experience in risk management, compliance, and quality assurance within clinical operations.
Demonstrated ability to drive innovation, process improvement, and operational efficiencies within clinical trial execution.
Experience interacting with regulatory agencies in preparation for, and during, clinical audits and inspections.
Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of an organization.
Demonstrated experience providing strong sponsor oversight of CROs and vendors, including reviewing CRO SOWs, vendor assumptions, study budgets, change orders, timelines, issue escalation, and vendor performance.
Experience evaluating CRO and vendor capabilities beyond line-item budget alignment, including whether the CRO/vendor has the operational experience, staffing, SOPs, infrastructure, and prior experience required to execute complex radiopharmaceutical studies.
Experience developing and pressure-testing study assumptions including screen failure rate, enrollment feasibility, site activation timelines, sample logistics, drug supply assumptions, imaging requirements, and vendor budget assumptions.

Nice To Haves

An advanced degree such as a Master's, PharmD, or Ph.D. in a relevant field is preferred.
Experience leading radiopharmaceutical, radioligand therapy, nuclear medicine, oncology, theranostic, imaging-intensive, or other highly specialized clinical development programs is strongly preferred.
Experience with radiopharmaceutical / RPT operational considerations preferred, including radioactive drug supply, shipment and handling, nuclear medicine site readiness, radiation safety requirements, hot blood/urine sample handling, central versus local analysis, gamma counter or local testing options, imaging/dosimetry workflows, specialty logistics vendors, and country-specific execution risks.

Responsibilities

Provide leadership and direction to the clinical operations function, ensuring alignment with the Company's overall program goals and objectives. Develop and communicate the vision and goals for the department.
Provide senior leadership for the planning, start-up, conduct, oversight, and closeout of complex radiopharmaceutical / RPT clinical studies, including studies involving radioactive drug administration, nuclear medicine sites, imaging/dosimetry, hot sample collection, and specialty logistics.
Lead and manage a team of Clinical Operations professionals and functional consultants, providing guidance, mentorship, and support. Foster a culture of accountability, collaboration, innovation, continuous improvement, and proactive issue escalation. Develop Clinical Operations staff in areas including CRO oversight, vendor management, RPT-specific trial execution, budget review, risk management, site readiness, and cross-functional leadership.
Oversee the execution of clinical trials for the Company, ensuring they are conducted in accordance with GLP, ICH guidelines, GCP, local regulatory guidelines, laws, radiation safety requirements, and relevant Company SOPs. Monitor trial progress, identify risks, and implement mitigation strategies. Ensure appropriate oversight of site activation, patient recruitment, screen failure assumptions, monitoring, data delivery, TMF quality, vendor performance, and study closeout.
Ensure that radiopharmaceutical-specific operational requirements are identified, planned, budgeted, and executed appropriately. This includes radioactive drug supply, drug shipment, decay timing, site receipt, administration readiness, nuclear medicine department readiness, radiation safety approvals, hot lab capability, imaging/dosimetry requirements, gamma counter or local testing options, radioactive blood/urine sample handling, radioactive sample shipment classification, packaging/container requirements, central versus local analysis strategy, and country-specific execution requirements.
Develop and implement the operational strategy for trial execution, implementation, monitoring, analysis, data delivery, and clinical dossiers for regulatory submission. Drive process improvements and efficiencies to optimize the conduct of clinical trials. Ensure that operational strategies are realistic, executable, and based on validated assumptions, including screen failure rates, recruitment feasibility, radioactive sample logistics, central/local testing needs, site capabilities, vendor capabilities, and local country constraints.
Provide strong sponsor oversight of CROs and vendors involved in trial conduct, either through the CRO or directly through the Company. Review CRO and vendor capabilities to determine whether they add value to Company processes and whether they have the experience required for radiopharmaceutical / RPT studies. Ensure CROs and vendors are selected not solely on line-item quote alignment but also on their demonstrated ability to execute the required work. Challenge vendor assumptions, budgets, timelines, change orders, staffing, and operational plans.
Assess and oversee specialty vendors required for radiopharmaceutical clinical trials, including CROs, central laboratories, specialty couriers, radiopharmaceutical logistics vendors, imaging vendors, dosimetry vendors, local laboratories, gamma counter providers, nuclear medicine support vendors, and sample handling vendors. Ensure vendors have appropriate SOPs, infrastructure, experience, documentation, and qualified personnel to support radioactive drug and hot sample logistics.
Provide oversight of country-specific and site-specific execution risks, including local regulatory requirements, radiation safety rules, import/export restrictions, site nuclear medicine capabilities, sample shipment feasibility, local laboratory options, investigator/site readiness, and local team input. Ensure that local experts, country leads, site staff, and sponsor team concerns are heard, documented, assessed, and escalated appropriately.
Ensure that local versus central analysis decisions are evaluated early from an operational, regulatory, QA, data integrity, budget, and timeline perspective. For radioactive blood/urine or other hot patient samples, ensure early assessment of whether samples should be shipped centrally or analyzed locally, including use of local laboratories, on-site gamma counters, site-based testing, comparability controls, data transfer requirements, and appropriate QA oversight.
Ensure appropriate planning and oversight for collection, processing, storage, packaging, shipment, receipt, analysis, and documentation of radioactive blood, urine, or other patient samples. Confirm that actual radioactivity levels, shipment classification, packaging/container needs, courier capabilities, country-specific requirements, and cost assumptions are validated before finalizing study budgets or operational plans.
Allocate resources effectively and efficiently to support the successful execution of clinical trials. Develop and manage the function's budget, ensuring optimal utilization of resources. With Project Management and Finance, ensure clinical trial budgets reflect realistic assumptions for RPT studies, including screen failure rates, radioactive drug supply, hot sample logistics, imaging/dosimetry, nuclear medicine site readiness, monitoring needs, local testing options, vendor scope, and country-specific operational complexity.
Review CRO scopes of work, study task lists, vendor budgets, and change orders to ensure they are based on realistic and validated operational assumptions. Challenge CRO and vendor change orders when costs appear to result from poor planning, incorrect assumptions, lack of experience, or failure to identify RPT-specific requirements upfront. Ensure budget risks and cost drivers are escalated with clear rationale and recommendations.
Collaborate closely with cross-functional program teams, including regulatory affairs, medical affairs, research and innovation, manufacturing, CMC, drug supply, radiation safety, nuclear medicine, QA, compliance, finance, legal, pharmacovigilance, data management, biometrics, project management, alliance partners, CROs, vendors, and investigative sites to ensure effective coordination and alignment in clinical trial activities.
Ensure compliance with applicable regulations, guidelines, and quality standards in all clinical operations activities. Implement quality assurance measures to maintain high standards of trial conduct, data integrity, patient safety, radiation safety documentation, protocol compliance, TMF completeness, and inspection readiness. Work closely with QA to ensure quality oversight of CROs, vendors, site readiness, hot sample handling, radioactive drug administration, imaging/dosimetry workflows, and local testing.
Identify and mitigate risks and issues that may impact trial timelines, budget, quality, patient safety, data integrity, or regulatory submissions. Implement risk management strategies and contingency plans to minimize potential disruptions. Maintain or oversee risk registers, issue trackers, assumption logs, decision logs, escalation plans, and mitigation strategies for high-risk operational workstreams.
Stay updated with the evolving regulatory landscape and ensure adherence to local and international regulatory requirements. Proactively address compliance issues and drive continuous compliance improvement within Clinical Operations, including requirements related to radiopharmaceutical trial conduct, radioactive drug handling, radiation safety, sample shipment, imaging/dosimetry, local testing, and clinical data integrity.
Stay abreast of industry trends, best practices, and technological advancements in clinical operations, radiopharmaceutical development, RPT trials, nuclear medicine operations, imaging/dosimetry, specialty logistics, and decentralized/local testing models. Represent the Company at relevant industry conferences, forums, and meetings to enhance the Company's visibility and promote thought leadership.